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Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Terminated
Phase 3

Conditions

Pain

Treatments

Drug: Bryonia alba, 5 CH
Drug: Ruta graveolens, 3 DH
Drug: Arnica montana, 5 CH
Drug: Hypericum perforatum, 5 CH

Study type

Interventional

Funder types

Other

Identifiers

NCT00222365
DCIC 03 10

Details and patient eligibility

About

This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.

The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Full description

We test the effectiveness of an homeopathic drug versus placebo and a temporal control group (patient with no add-on treatment) following orthopedic knee surgery.

All patients have a PCA of morphine for 24 hours after surgery. After this period they can take an oral tablet of morphine on request.

Group A: Patients with study treatment (homeopathy) allocation. Double blind group with 70 patients

Group B: Patients with placebo allocation. Double blind group with 70 patients

Group C: Temporal control group with patients who take only the morphine. Open group with 25 patients

The total power: 70 +70 + 25 = 165 patients

Main Objective:

  • To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Secondary Objectives:

  • To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty.
  • To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours.
  • To asses the placebo effect of the homeopathic treatment.

Main Assessment Criterion:

  • Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty

Secondary Assessment Criteria:

  • Morphine consumption between 0 and 72 hours after ligamentoplasty
  • Pain assessment at H0, H4, H24 and H72 using 10 cm Analogical Visual Scale

Inclusion Criteria:

  • age ranging from 18 to 60.
  • patients candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

  • patient with corticoid and immunodepressor treatment

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ranging from 18 to 60 years.
  • Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion criteria

  • Patients with corticoid and immunodepressor treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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